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填补56年空白:国家药监局批准最佳治疗高钾血症创新药上市

2020-01-06 包雨朦 澎湃新闻

1月6日, 记者从阿斯利康获悉,其新型口服降钾药物利倍卓(通用名:环硅酸锆钠散)获得中国国家药品监督管理局(NMPA)的上市批准,用于治疗成人高钾血症。利倍卓是该治疗领域首个在中国上市的创新药物,填补了约56年的空白期。据介绍,上一代的高钾血症治疗方法是1964年获批的静脉补钙,此后一直未有创新药物获批进入中国市场。2019年上半年,环硅酸锆钠散因独特的作用机制与临床疗效,可帮助高钾血症患者解决未

1月6日, 记者从阿斯利康获悉,其新型口服降钾药物利倍卓(通用名:环硅酸锆钠散)获得中国国家药品监督管理局(NMPA)的上市批准,用于治疗成人高钾血症。利倍卓是该治疗领域首个在中国上市的创新药物,填补了约56年的空白期。

据介绍,上一代的高钾血症治疗方法是1964年获批的静脉补钙,此后一直未有创新药物获批进入中国市场。

2019年上半年,环硅酸锆钠散因独特的作用机制与临床疗效,可帮助高钾血症患者解决未被满足的治疗需求,被国家药品监督管理局药品审评中心(CDE)纳入第二批《临床急需境外新药名单》,予以优先审评审批。

据悉,环硅酸锆钠是一种不溶于水、不被吸收的化合物,对钾离子具有高亲和力,能快速降钾并维持血钾稳定在安全阈值。此前,中国尚无有效治疗药物可在快速控制血钾的同时长期维持血钾稳定。

高钾血症是一种以血液中钾含量升高为特征的严重疾病,高发于晚期肾脏病和/或心力衰竭患者中,血液透析患者或使用常规心脏病药物的患者罹患高钾血症的风险更高。在我国约1.3亿的慢性肾脏病患者中,CKD4-5期患者并发高钾血症的患病率达40% 以上,这些患者面临更高心律失常及猝死风险。数据显示,近40%CKD患者因为心律失常/心脏骤停而死亡。

阿斯利康全球执行副总裁,国际业务及中国总裁王磊表示:“环硅酸锆钠散的获批上市意义非凡,为高钾血症患者提供了全新的治疗选择。面对中国基数巨大、亟需创新治疗和管理方案的慢性肾脏病患者,阿斯利康将持续加大投入,不断深耕肾脏病领域,为中国患者带来更多全球创新药物,并致力于通过创新药物推动病程管理,全方位助力提升慢性肾脏病的诊疗水平,更好地践行‘健康中国2030’战略。”

阿斯利康的中国总经理赖明隆在此前的采访中向澎湃新闻记者表示,除了高钾血症之外,阿斯利康近期上市的新药还将覆盖免疫肿瘤、呼吸、等方面。他透露,未来五年阿斯利康将有55个新的产品和适应症引进到中国。

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    2020-01-08 xuyu
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